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Clinical Trials/NCT00273507
NCT00273507TerminatedPhase 3

Neoadjuvant Chemotherapy in Resectable NSCLC Stages IB, IIA, IIB, and IIIA/T3 But Not IIIA/N2

Rigshospitalet, Denmark2 sites in 1 country270 target enrollmentStarted: January 1998Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
270
Locations
2
Primary Endpoint
Survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Detailed Description

Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Stages IB, IIA, IIB, IIIA/T3
  • •Lung function test allowing surgery
  • •Age 18-75 years

Exclusion Criteria

  • •Poor lung function
  • •Performance status 3-4
  • •Mediastinal lymph node involvement

Outcomes

Primary Outcomes

Survival

Secondary Outcomes

  • Time to progression
  • Complete resection rate

Investigators

Sponsor Class
Other

Study Sites (2)

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